Molecular Health GmbH

MolecularVersion MH Guide/BRCA -Software for Automated Analysis of HBOC Syndrome

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MH Guide/BRCA is optimized for identifying and reporting clinically-significant germline variants associated with hereditary breast and ovarian cancer syndrome (HBOC). This application, a module of MH Guide, assists human genetics laboratories in assessing germline variants in BRCA1, BRCA2, and other HBOC-related genes.

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Just like MH Guide, MH Guide/BRCA analyzes gene variants by comparing them with data from Dataome, one of the world’s largest knowledge bases of biomedical information. The software classifies variants through automated access to relevant databases and uses international scientific standards for variant classification. MH Guide/BRCA summarizes all of the relevant results in individual reports, giving users clear, specific indications of possible disease-causing genetic variations associated with HBOC.

Identify predisposition to HBOC – quickly, accurately, and efficiently

MH Guide/BRCA identifies and classifies germline variants in BRCA1/2 or other HBOC-relevant genes. Human genetics laboratories benefit from efficient, highly-automated analyses that automatically identify HBOC-relevant gene variants and pre-classify them according to ACMG standards.

MH Guide/BRCA accesses publicly-available databases for variant interpretation (e.g. ClinVar, BRCA Exchange, UTAH BRCA) via Dataome and ensures that the data is updated regularly. Users can store their own variant classifications in the protected area of their account. HBOC analyses according to the current state of science and research are now possible.

Approved for diagnostic use
MH Guide/BRCA is a module of MH Guide, which is approved as an IVD medical device in the EU and intended for diagnostic use.

Faster results
Automatic access to relevant databases, as well as variant pre-classification according to ACMG criteria and genotype-phenotype correlations, help healthcare professionals identify HBOC-related variants faster, and generate patient reports efficiently.

Easy to integrate
MH Guide/BRCA is a web-based application that can be immediately integrated into your lab routine. In addition, flexible interfaces make it possible to analyze standard data formats from the sequencing of commercially-available or proprietary gene panels, independent of the platform used.

Customizable analysis
MH Guide/BRCA is optimized for use in clinical routine. The filtering and editing options within the software allow quick access to the most important information.

Audited quality
Molecular Health is committed to meeting strict international standards – and is certified to EN ISO 13485. Users benefit from maximum safety and reliability.

The web-based software application MH Guide/BRCA can be easily integrated in the laboratory. It enables the annotation and interpretation of genetic variants from common NGS or other analysis platforms. The software allows users to generate highly-automated individual patient reports, each of which can be expanded and refined. The software generates clear, customizable report templates in various formats (PDF, JSON, XML) and is compatible with VCF and FASTQ data formats.

MH Guide/BRCA meets the highest standards of data privacy, data security, as well as risk and quality management.

Approved for clinical use
MH Guide/BRCA is a module of MH Guide, a software application approved in Europe as an IVD medical device (according to Directive 98/79/EC).

SaaS – individually scalable
MH Guide/BRCA is offered as scalable SaaS (Software as a Service) to suit small and large institutions alike.

Customizable patient reports
The design, content, and format of analysis reports can be adapted to individual needs on request.

Flexible input and output formats
MH Guide/BRCA can process the standard data formats VCF and FASTQ. Output formats are PDF, JSON, and XML.

Secure data transmission
MH Guide/BRCA provides secure transmission of patient data through advanced encryption standards (SSL/TLS, AES-256) and storage of patient data with controlled access authorization.

Guaranteed security of patient data
MH Guide/BRCA complies with GDPR in Europe, GenDG in Germany, and the Health Insurance Portability and Accountability Act (HIPAA) in the USA.

Efficient workflows in your laboratory
MH Guide/BRCA lets you optimize your everyday processes. The cloud-based software automates the interpretation of germline variants and delivers high-quality analyses.